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  • 1.  FDA Meeting Minutes

    This message was posted by a user wishing to remain anonymous
    Posted 05-Dec-2018 15:18
    This message was posted by a user wishing to remain anonymous

    Dear Forum-

    Are FDA's meeting minutes binding?

    Thank you for your help!


  • 2.  RE: FDA Meeting Minutes

    Posted 06-Dec-2018 05:26
    Short answer: no.  There is nothing ever really binding with the FDA - probably the closest agreements you will have are 513(g) Determinations and IDE Approvals.  Meeting minutes from Q-Submission meetings are intended to make sure correct information is conveyed and to record the discussion for posterity sake.  FDA personnel are also quite aware when they are providing concise answers to questions - usually their answers are the basic regulatory response.  Just because they said something in say a Q-Sub meeting for a PMA application, does not necessarily mean when they see the full information during a PMA application that things will change.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: FDA Meeting Minutes

    Posted 10-Dec-2018 09:10
    I have to echo Richard on this one. I'm familiar with at least 3 recent situations where companies had "agreements" with FDA (at least in the form of the review group) from meetings and/or pre-subs and yet when the final "management" review of the submission happened, something significant changed. Nothing is final with FDA until it is final, and even then, maybe not.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: FDA Meeting Minutes

    Posted 06-Dec-2018 08:08
    I essentially agree with Richard's response, but will provide a slightly different perspective from the drug side. Minutes of PDUFA meetings are issued as preliminary responses prior to the meeting and reflect FDA thinking based on the questions asked. Those responses can be modified based on the discussion at the meeting, although more often they are supplemented with meeting discussion points and any presentations that the sponsor makes.

    The minutes are not binding in the sense that new information can alter the thinking to either the benefit or detriment of the sponsor. That is, any agreement obtained at the meeting can change if new information becomes available.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 5.  RE: FDA Meeting Minutes

    Posted 06-Dec-2018 10:22
    ​Hi, The short answer is yes.
    The long answer is that my experience is with CDRH, and once the minutes are final FDA will hold you (and themselves) to what was concluded from the meeting.  I did refere back to presubission meeting minutes during a product review to show FDA what was decided and that the additional information that was being requested was out of scope.  FDA then agreed and recinded the request for addition data on that topic.

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    Sarah Parsons RAC
    Director Regulatory Affairs
    Pittsford NY
    United States
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    Original Message


  • 6.  RE: FDA Meeting Minutes

    Posted 07-Dec-2018 07:37
    ​Well I stand corrected!
    Legally binding no, but you better have either a change in the situation for the original advice and/or solid evidence for not taking the advice given.

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    Sarah Parsons RAC
    Director Regulatory Affairs
    Pittsford NY
    United States
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    Original Message


  • 7.  RE: FDA Meeting Minutes

    Posted 06-Dec-2018 11:03

    Hi, Anonymous -

    ​FDA meeting minutes are not binding, but do reflect FDA's current thinking based on the information package submitted and the discussion at the meeting.  Unless there is persuasive new information (such as new information about the product, new regulations, new guidances, or a change in best practice/standard of care related to the topic), the opinions expressed in the minutes are unlikely to change.  Even if your review team changes, the new reviewers will refer to the previous minutes. 

    Best regards,

    Cathy



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    Catherine Anderson PhD, RAC
    Senior Manager - Regulatory CMC
    Hillsborough NC
    United States
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    Original Message


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